World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
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Abstract

OBSERVATIONAL STUDY OF CLINICAL MANAGEMENT OF AND OUTCOME OF BACILLE CALMETTE-GUÉRIN VACCINE ADVERSE REACTIONS: BAGHDAD/ALRASAFA RESPIRATORY CENTER

*Salih Alsaria, M.Sc. and Taha Al-Azzawi, M.Sc.

ABSTRACT

Aim of the study: This study aims to describe the outcome of management of patients with localized BCG adverse events which include hypersensitivity reactions, abscesses at the injection site, and localized lymphadenopathy without intervention in Alrasafa Respiratory Center Baghdad, Iraq. Introduction: Although the Bacille Calmette-Guerin (BCG) vaccine is usually safe, a number of complications at the injection site and regional lymphadenitis can occur. Most of these complications are normal reactions. However, some unexpected complications may occur such as osteomyelitis and disseminated infection especially in immunocompromised children. Clinical features, treatment modalities and outcomes of these complications have not been clearly defined in literature. We aimed to determine the complications after BCG vaccine and outcomes of management in our Centre. Methods: observational study conducted over 4 years between January 2015 and January 2019, included healthy children aged 1-6 months, without underlying disease or drug use history, who were referred to our centre after BCG vaccine. At the first visit, the families were informed about the normal reaction following a BCG vaccination. Children who were seen in the clinic with a BCG adverse event (mostly due to parental anxiety) after reassurance each child was carefully clinically examined. They were followed-up between 1 to 6 months. Families were encouraged to contact the expert in our centre by telephone or interviews during the period of follow-up and in case of unexpected reactions. Results: local abscess, site reaction, suppurative lymphadenitis, and non suppurative lymphadenitis were observed. All children were treated conservatively without sequelae or complications. Only two infants who had systemic adverse event were given Anti TB. The first one got full recovery while the second one died. Conclusions: the Majority of BCG related lymphadenitis and local site reactions are a benign condition. All children were treated conservatively (watch and wait), and got full recovery. However, the minority of BCG vaccine complications is serious and a treatment is needed. In our study one child died due to disseminated complication and the other had full course of Anti TB and completely recovered.

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